Med-South Pharmacy, dba Partners In Care Orange Beach, AL, Sept. 28 (Nashville, TN).FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. conducted an investigation Dec. 20-21, 2006 at the facilities of Med-South Pharmacy dba Partners In Care, which was initiated in response to reports of injuries relating to relating to relate prep → concernant
relating to relate prep → bezüglich +gen, mit Bezug auf +acc betamethasone betamethasone /be·ta·meth·a·sone/ (ba?tah-meth´ah-son) a synthetic glucocorticoid, the most active of the antiinflammatory steroids; used topically as the benzoate, dipropionate, or valerate salts as an antiinflammatory, topically or acetate/betamethasone sodium phosphate sodium phosphate
Any of various sodium salts of phosphoric acid, especially NaH2PO4, Na2HPO4, and Na3PO4, widely used in pharmaceutical manufacturing, medicine, and chemistry. multi-dose injectable in·ject·a·ble
Capable of being injected. Used of a drug.
A drug or medicine that can be injected. drug product, which the pharmacy makes.
Additionally, on Feb. 21-23, and March 2, 2007, a follow-up inspection was conducted. During both instances, FDA documented serious violations.
The December 2006 investigation revealed the firm received at least 70 complaints associated with the use of betamethasone acetate/betamethasone sodium phos phate injectable suspension. The complaints included redness, large swollen areas, bruising at the injection site, rash, fever, and cellulitis Cellulitis Definition
Cellulitis is a spreading bacterial infection just below the skin surface. It is most commonly caused by Streptococcus pyogenes or Staphylococcus aureus. , with some patients requiring intravenous antibiotics.
On Dec. 22, 2006, the firm initiated a voluntary recall of two lots. The company later revealed a new formulation had been implemented to "improve workflow", and an incorrect amount of benzalkonium chloride benzalkonium chloride /ben·zal·ko·ni·um chlo·ride/ (ben?zal-ko´ne-um) a quaternary ammonium compound used as a surface disinfectant and detergent, topical antiseptic, and antimicrobial preservative. (BZK BZK Ministerie van Binnenlandse Zaken en Koninkrijksrelaties
BZK Benzalkonium Chloride (topical antiseptic)
BZK Billy Ze Kick (band)
BZK Briansk (Russia) ), used as a preservative preservative
Any of numerous chemical additives used to prevent or slow food spoilage caused by chemical changes (e.g., oxidation, mold growth) and maintain a fresh appearance and consistency. Antimycotics (e.g. , had been added to the product.
On March 2, FDA conducted a follow-up investigation and found there was a failure to establish and follow written procedures to prevent microbiological contamination of injectable drug products claiming to be sterile.
Specifically, the firm's manufacturing process had not been validated for the injectable drug products. In addition, the filters used to sterilize sterilize /ster·i·lize/ (ster´i-liz)
1. to render sterile; to free from microorganisms.
2. to render incapable of reproduction.
1. injectable drug products had not been tested for integrity; smoke studies had not been conducted in the critical areas; and, particulate matter particulate matter
n. Abbr. PM
Material suspended in the air in the form of minute solid particles or liquid droplets, especially when considered as an atmospheric pollutant.
Noun 1. was not being monitored. The autoclave autoclave
Vessel, usually of steel, able to withstand high temperatures and pressures. The chemical industry uses various types of autoclaves in manufacturing dyes and in other chemical reactions requiring high pressures. cycles used to terminally sterilize injectable suspension drug products had not been validated and there was no verification of their effectiveness with biological indicators.
The company failed to test each batch of injectable drug products purporting to be sterile and/or pyrogen-free to determine conformance to such requirements. For example, the firm tests finished injectable drug products for sterility on a monthly basis only.
The inspection revealed there was a failure to ensure all components and injectable drug product containers and closures were, at all times, handled and stored in a manner to prevent contamination. Specifically, on Feb. 21 and 22, FDA documented empty, open, sterilized ster·il·ize
tr.v. ster·il·ized, ster·il·iz·ing, ster·il·iz·es
1. To make free from live bacteria or other microorganisms.
2. glass vials, which were exposed to environmental contamination.
The company did not test each batch of injectable drug product to determine conformance to final specifications, including identity and strength of each active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. , before release and distribution. The firm did not conduct product testing on all batches of its product prior to release.
The inspection revealed a failure to reject injectable drug product which failed to meet established standards or specifications and any other relevant quality control criteria. For instance, distributed methylprednisolone acetate methylprednisolone acetate
Depo-Medrol, Depo-Medrone (UK), Methysone (CA), Unimed (CA)
Pharmacologic class: Glucocorticoid
Therapeutic class: Antiasthmatic, anti-inflammatory (steroidal), immunosuppressant
which failed to meet the established assay specifications, was distributed without conducting any reprocessing Reprocessing may refer to:
There were no written procedures for production and process controls to assure the products had the identity, strength, quality, and purity they claimed to have and there was a failure to establish laboratory controls, including scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure the drug products conform to appropriate standards of identity, strength, quality and purity.
The company failed to establish a quality control unit which has the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products and the authority to review production records to assure no errors have occurred or, if errors have occurred, they have been fully investigated.
And, the letter also stated: "The company failed to verify the identity of each component of injectable drug product and its conformance with all appropriate written specifications for purity, strength, and quality."
The firm did not conduct and document a thorough investigation of any unexplained discrepancy or failure of a drug product to meet its specifications or to extend the investigation to other batches which may have been associated with the particular failure or discrepancy.
Specifically, the firm failed to conduct complete root cause investigations for three complaints involving injectable drug products, which could not be drawn into the syringe or discharged from the syringe.
There was a failure to assure all injectable drug products met applicable standards of identity, strength, quality, and purity at the time of use by establishing an expiration date Expiration Date
The day on which an options or futures contract is no longer valid and, therefore, ceases to exist.
The expiration date for all listed stock options in the U.S. determined by appropriate stability testing there was no written testing program designed to assess the stability of your injectable drug products.
The letter further said the company did not ensure all injectable drug products, set aside and held in unlabeled conditions, were sufficiently identified to preclude mislabeling mislabeling,
n 1. the inaccurate identification of a product in which the label lists ingredients or components that are not actually included within the product.
2. and the company failed to prepare batch production and control records for each batch of drug product containing complete information, including documentation where each significant step in the manufacturing of the product was accomplished.
There were no written procedures for cleaning and maintenance of equipment used in the manufacture of the product. As well as there were no established written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures.
The inspection also found there was a failure to routinely calibrate To adjust or bring into balance. Scanners, CRTs and similar peripherals may require periodic adjustment. Unlike digital devices, the electronic components within these analog devices may change from their original specification. See color calibration and tweak. automatic, mechanical, or electronic equipment according to a written program designed to assure proper equipment performance. Specifically, the firm did not routinely calibrate scales, the autoclave, or sonicators used to manufacture the products. In addition, the firm did not have any written procedures addressing equipment calibration.
Further, FDA said: "The company failed to calibrate instruments at suitable intervals in accordance with an established written program. For example, the firm routinely did not calibrate pH meters. In addition, it did not have any written procedures addressing instrument calibration."
There were no written procedures describing in sufficient detail the control procedures employed for the issuance of labeling and the company failed to retain and store, under conditions consistent with product labeling, reserve samples which are representative of each lot or batch of finished injectable drug product.
The firm failed to maintain individual equipment logs documenting the date, time, product, and lot number of each batch of finished injectable drug product processed and it failed to ensure employees engaged in the proper training in CGMP compliance.
The letter went on to say: "The company did not reject components which failed to meet required specifications and it failed to calculate actual yields and percentages of theoretical yield at the conclusion of each appropriate phase of manufacturing." Val; QCIQS; 14239W
* No written procedures to prevent microbiological contamination
* Manufacturing process had not been validated for the injectable drug products
* Did not conduct and document a thorough investigation of failure of a drug product to meet its specifications
* No written procedures for cleaning and maintenance of equipment used