# FDA 483 - MedPark Pharmacy, LLC - May 23, 2016

Source: https://www.keypedia.com/records/483/medpark-pharmacy-llc/efe7b4d2-eae6-46e9-87dd-2f60ecf50f27

> FDA 483 for MedPark Pharmacy, LLC on May 23, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MedPark Pharmacy, LLC
- Inspection Date: 2016-05-23
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: This FDA Form 483 was issued to MedPark Pharmacy, located at 2002 Medical Parkway, Suite 170, Sajak Pavillion, Annapolis, MD 21401, a producer of sterile and non-sterile drug products. The inspection occurred on May 9-10, 2016, and May 23, 2016, with the report issued to Joan M. Phillips, Pharmacist, on May 23, 2016.

Five observations were noted:

1.  **Inadequate Product Testing and Release:** The firm does not consistently test sterile and non-sterile drug batches for conformance to final specifications, identity, and strength before release. A Trimix batch recall on May 3, 2016, due to Alprostadil failing potency, exemplifies this.
2.  **Insufficient Sterility Testing:** Batches of sterile drug products are not consistently tested for objectionable microorganisms. Despite being rendered sterile by a specific process, products are not consistently checked for contamination prior to distribution. Sterility testing has been limited since sterile compounding began in March 2016.
3.  **Lack of Depyrogenation for Glassware:** The firm does not use depyrogenated glassware for sterile drug product preparation and lacks equipment or a validated process for depyrogenation. Glassware is cleaned by a specific process, but not depy

## Related Documents

- [483 - 2017-03-10](https://www.keypedia.com/records/483/medpark-pharmacy-llc/4552fa94-5485-45bb-8c22-561f29c82639)
- [WARNING_LETTER - 2017-03-10](https://www.keypedia.com/records/warning_letter/medpark-pharmacy-llc/5a7918f4-1e3f-4614-83dd-79856fc231e9)

## Related Officers

- [investigator](https://www.keypedia.com/people/tajah-l-blackburn/27b25d9d-3186-4b3a-a511-2f693d3c889a)
- [Visiting Scientist](https://www.keypedia.com/people/jai-p-singh/3843c2c6-a3b1-43b3-96f6-c3f1a72dc85b)

Company: https://www.keypedia.com/companies/medpark-pharmacy-llc/47068ce2-141b-4680-99d7-7574e95e8f02

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa