# FDA 483 - Consolidated Chemical, Inc - May 22, 2008

Source: https://www.keypedia.com/records/483/consolidated-chemical-inc/b919bc81-7af9-428c-8c06-d822646c51c3

> FDA 483 for Consolidated Chemical, Inc on May 22, 2008. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Consolidated Chemical, Inc
- Inspection Date: 2008-05-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 was issued to Care-Tech Labs Inc., a human drug manufacturer located at 3224 S Kingshighway, Saint Louis, MO 63139. The inspection was conducted from April 28, 2008, to May 22, 2008.

The document lists 23 observations related to deficiencies in quality control, manufacturing processes, and facility maintenance. Key violations include:

**Quality Control and Laboratory Issues:**
*   **Inadequate Laboratory Controls:** Active ingredient samples were not consistently bracketed by standard injections during HPLC analysis. Calculations for %PCMX used standard areas not found in batch records, and system suitability failures were not investigated.
*   **Deficient Test Methods:** Method CCQC10.0 for finished product sampling lacked time/temperature specifications for cooling. Microbiological testing methods (CCQC39.1) were not adequately validated, lacking preparatory tests for inhibitory properties, comparison to USP methods, and proper use of controls. HPLC assay method CCQC35.1 did not describe critical sample preparation steps (heating, mixing, cooling).
*   **Lack of Method Equivalency Evaluation:** The firm failed to evaluate the equivalency of HPLC to GC for Techni-care surgical scrub active ingredient (Chloroxylenol PCMX) analysis, as required by the monograph.
*   **Insufficient Out-of-Specification (OOS) Investigations:**

## Related Documents

- [483 - 2008-05-22](https://www.keypedia.com/records/483/consolidated-chemical-inc/845a1298-60d8-4da9-bf3a-030620151818)
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Company: https://www.keypedia.com/companies/consolidated-chemical-inc/f456a0b0-004d-48ed-904f-c2020577ace9

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c