# FDA 483 - Specialty Compounding, LLC - March 22, 2013

Source: https://www.keypedia.com/records/483/specialty-compounding-llc/fa67f447-8ff9-4c10-b02c-51f10d4e295d

> FDA 483 for Specialty Compounding, LLC on March 22, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Specialty Compounding, LLC
- Inspection Date: 2013-03-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in the facility's sterile drug product manufacturing.

**Facility and Operations:** The firm prepares various injectable and inhalation drug products, including Magnesium Sulfate, Acetylcysteine, Bupivacaine Hydrochloride, DMPS, Cefazolin, Furosemide, Morphine Sulfate, Calcium Gluconate, Hydromorphone, Fentanyl, Sodium Phenylbutyrate, Glutathione/Adenosine Triphosphate, Hydrogen Peroxide, Methylcobalamin, and Methylcobalamin/Folic Acid. Operations involve ISO 5 Laminar Flow Hoods (LFH), ISO 7 clean rooms, and ISO 8 prep/ante rooms.

**Violations and Observations:**
1.  **Microbiological Contamination Prevention:** Procedures are not established to prevent contamination.
    *   Employees touched bare skin with gloved hands, then resumed filling operations (e.g., Magnesium Sulfate, Acetylcysteine) without changing gloves.
    *   A pharmacist knelt on the ISO 7 clean room floor to retrieve items, then continued working without re-gowning or changing gloves, handling components for multiple products (e.g., Bupivacaine, DMPS).
2.  **Personnel Gowning:** Clothing is inappropriate.
    *   Gowning attire (bunny suit with foot covers, single hair net, safety glasses, single ear-loop mask, single pair

## Related Documents

- [483 - 2013-09-13](https://www.keypedia.com/records/483/specialty-compounding-llc/1729063a-2622-40c3-933b-40c06587e607)
- [483 - 2015-05-05](https://www.keypedia.com/records/483/specialty-compounding-llc/64764af0-8f28-41a9-ba49-47dec0517e59)

## Related Officers

- [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/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c