# FDA 483 - Specialty Compounding, LLC - September 13, 2013

Source: https://www.keypedia.com/records/483/specialty-compounding-llc/1729063a-2622-40c3-933b-40c06587e607

> FDA 483 for Specialty Compounding, LLC on September 13, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Specialty Compounding, LLC
- Inspection Date: 2013-09-13
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 details observations from an inspection of a firm that prepares various sterile drug products from bulk non-sterile APIs and excipients, which are then either sterilized or aseptically filled.

Key observations include:
*   **Failure to thoroughly review discrepancies:** The firm failed to review unexplained discrepancies or batch failures to meet specifications, even for distributed batches.
*   **Sterilization process not validated:** The sterilization process for sterile drug products is not validated.
*   **Inadequate smoke studies:** Smoke studies are not performed under dynamic conditions in ISO 5 Laminar Flow Hoods used for aseptic processing.
*   **Insufficient QC review of records:** Drug product production and control records are not reviewed and approved by the quality control unit before batch release or distribution.
*   **Deficient complaint records:** Complaint records lack investigation findings, follow-up, and essential details like drug product name/strength, lot number, complainant name, nature of complaint, and reply.
*   **Incomplete batch records:** Batch production and control records do not contain complete information.
*   **Inappropriate personnel clothing:** Clothing of personnel engaged in drug product processing is not appropriate for their duties.
*   **Lack of written procedures:** No written procedures exist for production and process controls to assure drug product identity, strength, quality, and purity. Written procedures for equipment cleaning and maintenance are also absent.
*   **No stability testing program:** There is no

## Related Documents

- [483 - 2013-03-22](https://www.keypedia.com/records/483/specialty-compounding-llc/fa67f447-8ff9-4c10-b02c-51f10d4e295d)
- [483 - 2015-05-05](https://www.keypedia.com/records/483/specialty-compounding-llc/64764af0-8f28-41a9-ba49-47dec0517e59)

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/jamillah-selby/40c6be13-1980-4b94-9d4d-9e644fad6f8e)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)
- [Investigator](https://www.keypedia.com/people/lucas-b-leake/f4c191d4-25d1-4eb8-8dc9-4d1aa483a441)

Company: https://www.keypedia.com/companies/specialty-compounding-llc/e081135c-6e13-448e-bdcd-f1b84c86cbec

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9