Bug problems in water plague contract maker of shampoo for head lice. (Human Drugs).

Piedmont Laboratories, Gainsville, GA, Atlanta District

Piedmont Laboratories, a Gainsville, GA-based contract manufacturer and packager of medicated shampoos, received a 12-item 483, largely due to water quality and questions about the reliance of USP standards.

Investigators Penny McCarver and Jawaid Hamid conducted the audit of Piedmont, which also makes drain cleaners, brake fluids and hairsprays, apparently in the same facility.

The inspection was triggered by an anonymous complaint alleging pseudomonas in the facility's water. According to the EIR, Piedmont used deionized water to manufacture all products except their lice killing shampoo and conditioner and a topical pain relief spray.

Used water system, bacteria noted

McCarver and Hamid noted Piedmont's current water system was installed in 1997, which the records said was used, but did not specify how old.

"Due to problems with total bacteria counts exceeding their bacteriological purity specifications and the presence of gram-negative bacteria in this water system the firm has instituted several changes beginning in May 2001," the FDAers wrote.

The EIR continued that due "to continuing problems with total bacteria counts/gram-negative bacteria even after the addition of the filters, etc. the firm began installation of an ozonator (used for chemical sanitation) during the last week of August."

The installation was not completed at the time of the inspection. The EIR stated that construction on the new water system began on Aug. 25, 2001, with an estimated completion date of late Sept. 2001, and completed validation is expected to be completed in late Oct. 2001.

In their write-up, the FDAers hit Piedmont with failure to validate the water system to ensure that it met specifications for bacteriological purity and that it met USP requirements for water conductivity, total organic carbons, and that it contained no added substances.

FDA also discussed with the firm that "simply testing the water after heating it to determine that it meets the USP specifications for purified water" was not sufficient. FDA noted: "USP does not provide adequate scientific justification that their water system can consistently produce purified water, USP, and does not constitute a validation."

McCarver also noted: "I also discussed with the firm that the distinction they are making between the deionized water and purified water, USP is not justified. The deionized water is heated to [an unspecified temperature] (which the firm calls pasteurization) so that it can meet their purified water raw material specification for bacteriological purity. This is just an additional step in their deionized water purification process. The entire process must be validated to ensure that the water meets the USP requirements for purified water as outlined in the USP monograph."

The 483 also stated the firm had no data to support the bacteriological purity of the purified water used to manufacture a single lot of lice killing shampoo released May 17, 2001. "The USP purified water results table indicates that the results for the bacteriological purity are attached in a report but this data could not be located."

The firm also failed to conduct an investigation (until after the initiation of the inspection) to determine the cause of multiple OOS microbiological test results of the water system.

According to the 483, Piedmont "failed to conduct an investigation until 9/4/01 (after the initiation of this inspection) to determine the cause of multiple, continuing out-of-specification microbiological test results of the deionized water system for total bacterial count and the presence of gram negative bacteria...that were initially reported in March, 2001."

The FDAer continued that Pseudomonas sp., Vibrio sp., and Aeromonas sp. "have continued to be reported in water samples through August 17, 2001."

According to General Manager Thomas Misgen, Piedmont was still conducting an ongoing investigation into this. Specifically, the firm began a March 8, 2001, investigation to determine the cause of contamination, but had failed to "document this in a formal written laboratory/manufacturing investigation."

In addition, the FDAers pointed out that Piedmont failed to perform routine sanitation of its water system.

"The firm failed to clean/sanitize the water system on multiple occasions when bacteriological specifications were exceeded in the past 18 months," the investigators wrote. "Furthermore, the firm has no written procedures requiring cleaning/sanitation of the water system when the specifications are exceeded."

According to the EIR, following six separate testing dates in 2000 that showed elevated bacteriological levels, sanitation of the water systems "was not performed until...weeks after these results were reported as noted in the logbooks." Similarly deionized water test results for 2001 "indicated that bacteriological specifications were exceeded and/or positive for gram-negative bacteria...weekly testing timepoints. Sanitation routinely was performed...weeks after these results were reported."

Also, the investigators stated that changes made to the water system had not been reviewed or approved by the QA manager and the firm failed to perform routine sanitization of the water system.

The company did not return calls for comment prior to deadline.

Piedmont Labs., Gainsville, GA, 8/30-9/11/01, Doc. 109369M, $26.50 plus retrieval.