# FDA WARNING_LETTER - ChemRite CoPac, Inc. - July 15, 2016

Source: https://www.keypedia.com/records/warning_letter/chemrite-copac-inc/cd5867f9-7a89-488c-a0e5-7f76f8fbaf40

> FDA WARNING_LETTER for ChemRite CoPac, Inc. on July 15, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: ChemRite CoPac, Inc.
- Inspection Date: 2016-07-15
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: The FDA issued a Warning Letter to ChemRite CoPac, Inc. following an inspection from June 6 to July 15, 2016, which found significant CGMP violations, rendering their drug products adulterated.

Key violations include:
1.  **Inadequate Separate Areas (21 CFR 211.42(c)):** The firm manufactures OTC oral drug products using the same equipment as toxic non-pharmaceutical industrial products (e.g., car care products, leather treatments). This poses a high risk of contamination due to the difficulty of removing industrial product ingredients from shared equipment. The FDA requires the firm to discontinue manufacturing drugs on shared equipment or provide a plan for dedicated manufacturing areas, and conduct a risk assessment for all previously produced drugs on shared equipment, including potential recalls.
2.  **Insufficient Laboratory Testing (21 CFR 211.165(b)):** The firm released at least 24 batches of an OTC drug product between 2013 and 2015 without performing required microbiological testing for *Pseudomonas aeruginosa*, despite batch records reporting its absence. The contract lab's raw data showed no such analysis. The firm's response, citing customer-obtained results, was deemed inadequate. The FDA demands an investigation into this failure, root cause analysis, a timeline for retain testing, and a retrospective review of all released lots for complete microbiological testing.
3.  **In

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## Related Officers

- [Program Division Director](https://www.keypedia.com/people/art-o-czabaniuk/37f1e249-9ee6-4275-9c28-391d93659b85)

Company: https://www.keypedia.com/companies/chemrite-copac-inc/a81a399e-073f-4c5d-a41f-19bc9d0c0bc3

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03