# FDA WARNING_LETTER - PrimaPharm Inc. - May 14, 2008

Source: https://www.keypedia.com/records/warning_letter/primapharm-inc/f000ff8a-86e3-44c5-8e58-a9022137ff5e

> FDA WARNING_LETTER for PrimaPharm Inc. on May 14, 2008. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: PrimaPharm Inc.
- Inspection Date: 2008-05-14
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of PrimaPharm Inc.'s drug manufacturing facility in San Diego, California, from May 1-14, 2008, revealed significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 211), causing their drug products to be adulterated under 21 U.S.C. § 351(a)(2)(B). The inspection also found the firm was manufacturing and marketing unapproved new drugs, violating 21 U.S.C. § 355(a), and that these drugs were misbranded, violating 21 U.S.C. § 352(f)(1).

Key CGMP deviations included:
1.  **Inadequate investigations:** Failure to thoroughly investigate unexplained discrepancies, such as media fill failures and out-of-specification results, and to assess the impact on other batches.
2.  **Microbiological contamination prevention failures:** Lack of continuous environmental monitoring, inadequate facility design (e.g., direct entry into aseptic areas), and deficient media fill validation procedures.
3.  **Environmental monitoring deficiencies:** Failure to sample critical surfaces, perform viable air sampling at the conclusion of product fills, and establish appropriate action limits for personnel monitoring.
4.  **Inadequate test method validation:** Lack of defined methods for determining operator qualification for visual inspection and undocumented retraining frequency.
5.  **Insufficient cleaning and disinfection

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- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)
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Company: https://www.keypedia.com/companies/primapharm-inc/bfb85e8d-f916-4a4e-b0e8-df02707df137

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b