Amneal cited for lapses on OOS batches, annual reviews.

Amneal Pharmaceuticals, Paterson, NJ Parsippany District

During his inspection of Amneal Pharmaceuticals July 5-17, 2007, FDA investigator Douglas Kovacs found that the drug manufacturer had not sufficiently investigated failure of batches of product to meet specifications.

Specifically, two batches of Acetaminophen, Phenylephrine and Diphenhydramine Hydrochloride 325/5/12.5 mg Tablets were manufactured in a campaign of batches and were rejected due to out-of-specification (OOS) results for assay and/or content uniformity, he noted in the FDA Form 483. One batch had an OOS result for content uniformity for Diphenhydramine. The manufacturing investigations concluded that the lumpy nature of the Diphenhydramine API may have contributed to the failures and corrective actions included a change to the mesh size for screening the API and revalidation of the process. However, the inspector noted, the manufacturing investigation did not include evaluations of each finished product batch manufactured in the campaign or an assessment of the API lots used for these batches.

Kovacs also found that Amneal did not follow its written procedures that called for evaluations to be conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.

Specifically, Annual Product Review (APR) for Folic Acid, USP 1 mg Tablets for July 2005 through June 2006 was not conducted within the timeframe specified in SOP Annual Product Review. The review was not completed until Feb. 9, 2007, after the required time period set out in the company's SOP.

Amneal Pharmaceuticals, Paterson, NJ, 07/05-17/2007, Doc. 110113M, $3 plus retrieval