# FDA 483 - dca, inc.,  - October 18, 2016

Source: https://www.keypedia.com/records/483/dca-inc/1f7b9d59-5235-4c7a-ad88-494660dd81bb

> FDA 483 for dca, inc.,  on October 18, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: dca, inc., 
- Inspection Date: 2016-10-18
- Product Type: Drugs
- Office Name: New England District Office
- Summary: The FDA Form 483 inspection revealed significant deficiencies at a drug manufacturing facility producing hormones, teratogenic materials, antibiotics, and controlled substances.

**Equipment and Cleaning Issues:**
*   Equipment and utensils are not cleaned and sanitized at appropriate intervals.
*   The firm lacks cleaning validation data for (b)(4) and (b)(4) as cleaning agents for drug production equipment.
*   (b)(4) is used for cleaning without purified water as a final rinse.

**Cross-Contamination and Facility Design:**
*   The flow of materials is not designed to prevent contamination.
*   Potent drug substances (hormones, teratogenic materials, antibiotics, controlled substances) are handled without adequate containment, segregation, or cleaning of work surfaces, equipment, and personnel, leading to cross-contamination risks in the general pharmacy (including shared hoods, (b)(4)).
*   A teratogenic drug (Allopurinol/Colchicine) was produced in the same hood and with the same equipment as other drugs (Prednisolone Liquid) without cleaning validation data.

**Complaint Investigations:**
*   Complaint investigations are inadequate and not always completed.
*   Specific examples include:
    *   A burning sensation complaint for Estriol 0.5mg/mL Vag with no documented investigation.
    *   A complaint of abnormal bleeding and breast lumps for Progesterone 300mg, which was not

## Related Officers

- [Nealie C. Newberger](https://www.keypedia.com/people/nealie-c-newberger/4b7addde-1217-4495-bac2-2f7e3fe2e780)

Company: https://www.keypedia.com/companies/dca-inc/e0956546-0655-4007-8260-8d793bb34259

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144