# FDA 483 - Essential Pharmacy Compounding - May 22, 2015

Source: https://www.keypedia.com/records/483/essential-pharmacy-compounding/66304204-181e-46fe-a9ea-960204ef4f1f

> FDA 483 for Essential Pharmacy Compounding on May 22, 2015. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Essential Pharmacy Compounding
- Inspection Date: 2015-05-22
- Product Type: Drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: The FDA inspected Essential Pharmacy Compounding, a producer of sterile human and veterinary drug products, from May 12-22, 2015, and issued a Form 483 with 12 observations.

**Key Violations and Observations:**

1.  **Inadequate Sterilization Process Validation:**
    *   Smoke studies for static airflow lacked documented management evaluation; dynamic studies were undocumented.
    *   An operator was observed not following sterile drug production procedures in an ISO 5 hood, including resting arms on surfaces.
    *   Media fills for sterile injectable drugs were not performed under representative worst-case aseptic processing conditions.
    *   Primary sterilization steps (redacted) lacked challenge to establish upper bio-burden limits; incoming non-sterile APIs and formulated products were not evaluated for bio-burden.

2.  **Inappropriate Personnel Clothing:**
    *   Employees had exposed eyes and foreheads in the ISO 5 cleanroom.
    *   An employee cleaning an ISO 5 hood placed exposed forehead/eyes and upper body inside it.
    *   Sterile gowns were reused after exiting and returning to sterile production areas.

3.  **Deficient Environmental Monitoring:**
    *   Environmental monitoring (viable, non-viable, personnel) was not conducted daily during production, despite production occurring frequently.
    *   Pressure differentials between the "Buffer room" (ISO 5) and "Ante Room

## Related Documents

- [483 - 2015-05-22](https://www.keypedia.com/records/483/essential-pharmacy-compounding/88e4c181-913e-4bf6-b144-cc851b5edf2f)
- [483 - 2017-07-27](https://www.keypedia.com/records/483/essential-pharmacy-compounding/b475eb02-fc16-4302-971d-f4a8a7384c87)
- [STATE_REFERRAL_LETTER - 2017-07-10](https://www.keypedia.com/records/state_referral_letter/essential-pharmacy-compounding/3ddb5181-36bc-415d-8457-5dae6762381c)

## Related Officers

- [Regulatory Counsel](https://www.keypedia.com/people/jenny-agila-sefen/6ce0e72d-5b05-476c-8553-c0ae93745ee2)
- [Eric Mueller](https://www.keypedia.com/people/eric-mueller/c2da0580-e8b7-41d8-94b6-3579d2bfad8b)
- [Compliance Officer, CDER, Office of Manufacturing](https://www.keypedia.com/people/joseph-r-lambert/d2968fda-8e5e-433a-b60b-f68aaef3b7b0)

Company: https://www.keypedia.com/companies/essential-pharmacy-compounding/70adb355-4e55-4511-9423-d685086526a3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8