# FDA 483 - Chen Shwezin, Inc. dba Park Compounding Pharmacy - April 03, 2018

Source: https://www.keypedia.com/records/483/chen-shwezin-inc-dba-park-compounding-pharmacy/37fe8f2a-4c01-4dcf-858d-20684702f0c7

> FDA 483 for Chen Shwezin, Inc. dba Park Compounding Pharmacy on April 03, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chen Shwezin, Inc. dba Park Compounding Pharmacy
- Inspection Date: 2018-04-03
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: The FDA Form 483 inspection revealed significant deficiencies at the facility regarding drug product testing and equipment maintenance.

**Testing and Release:** The firm failed to conduct appropriate laboratory determination of identity and strength for each active ingredient prior to drug product release. Potency testing on three finished drug products over eight months did not adequately represent all distributed products or dosage forms, neglecting factors like production difficulty or active ingredient amount. Examples of products distributed without adequate assurance of meeting labeled strength claims include Lidocaine + Tetracaine 23+7% cream, Diclofenac suppository 100 mg, Trichloroacetic Acid 35% solution, Cantharidin Plus liquid, and Benzocaine + Lidocaine + Tetracaine 20+8+4% Lipoderm.

**Equipment and Utensil Maintenance:** Equipment and utensils were not cleaned, maintained, and sanitized at appropriate intervals. There were no written cleaning, sanitization, or maintenance procedures. Observed issues included:
*   Capsule plates designated clean contained powder residue.
*   Visible, loose powder on capsule machines.
*   An apparent hair stuck to residue on an ointment mill designated clean.
*   Spatulas used for product transfer had missing sections, creating rough surfaces.
*   Damaged powder containment hoods sealed with duct tape and packaging tape, showing powder residue on exposed adhesive.
*   Lack of documentation for cleaning process effectiveness in removing drug product residues and cleaning agents for encapsulation components

## Related Documents

- [483 - 2015-09-11](https://www.keypedia.com/records/483/chen-shwezin-inc-dba-park-compounding-pharmacy/6ee6799d-a418-4ce6-88af-2362cba7f4c8)
- [STATE_REFERRAL_LETTER - 2018-03-26](https://www.keypedia.com/records/state_referral_letter/chen-shwezin-inc-dba-park-compounding-pharmacy/0b9c3233-2854-4e41-b845-6451c29a80da)

## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

Company: https://www.keypedia.com/companies/chen-shwezin-inc-dba-park-compounding-pharmacy/cba0dc40-59f5-4eeb-a58a-2b59fb83af28

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