# FDA 483 - Rancho Park Compounding Pharmacy - May 07, 2019

Source: https://www.globalkeysolutions.net/records/483/rancho-park-compounding-pharmacy/916d6f6f-36a1-4eea-87f6-20d40afe813b

> FDA 483 for Rancho Park Compounding Pharmacy on May 07, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rancho Park Compounding Pharmacy
- Inspection Date: 2019-05-07
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: An FDA Form 483 was issued following an inspection of a sterile compounding lab, revealing multiple deficiencies in facility design, operations, and aseptic processing.

Observations included visibly dirty equipment and surfaces in ISO 5 Laminar Flow Workstations (LAFWs), with yellowish-brown stains and spots on stainless steel surfaces, curved metal hooks, cap screws, and HEPA filter covers. Non-microbial contamination was noted in ISO 7 buffer and anterooms, including chipped ceiling material, discolored bolt screws, and dirty HEPA filter covers.

Personnel were observed blocking first-pass air during aseptic manipulations, specifically when capping sterile dropper tips for Dexamethasone Ophthalmic Soln. Non-sterile wipes were used with disinfecting agents in ISO 5 LAFWs, and materials were not properly disinfected before entering aseptic processing areas.

The facility's design included dust-collecting overhangs like wall cable raceways in ISO 7 areas that were difficult to clean. Gowning procedures were improper, with gowns touching the floor and wet spillage. Unsealed and loose ceiling tiles, including a cracked light cover and unsealed light fixture frame, were found in the ISO 7 buffer room. The gowning room's layout in the ISO 7 anteroom was deemed to permit poor flow of personnel and materials, leading to potential contamination of gowning apparel.

## Related Documents

- [STATE_REFERRAL_LETTER - 2019-04-23](https://www.globalkeysolutions.net/records/state_referral_letter/rancho-park-compounding-pharmacy/7f4ce210-e747-457d-b2b1-22aa9ae36f29)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.globalkeysolutions.net/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.globalkeysolutions.net/companies/rancho-park-compounding-pharmacy/83062093-a562-423a-9748-a99bf34305fe

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b