# FDA 483 - Shertech Pharmacy - July 02, 2019

Source: https://www.keypedia.com/records/483/shertech-pharmacy/f37624b0-9045-4fab-a2a9-f6e3a14ebb41

> FDA 483 for Shertech Pharmacy on July 02, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shertech Pharmacy
- Inspection Date: 2019-07-02
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: An FDA inspection revealed significant deficiencies at a facility producing sterile injectable radiological drug products, specifically Mertiadiate-Tc99m LEU.

Key violations include:
- **Aseptic Processing:** Personnel used non-sterile gloves during sterile drug product preparation.
- **Cleanroom Maintenance:** Sporicidal agents were not used in cleanrooms or ISO 5 aseptic processing areas; only non-sterile disinfectants were used.
- **Facility Design & Air Quality:** ISO-3 LAFH hoods were located within an ISO-8 Pharmacy Area without demonstrated prevention of poor-quality air influx (no smoke studies). Hoods were shut off overnight and only wiped with non-sterile solutions. Differential pressure between classified areas was not monitored. The ISO-8 Pharmacy Area had potential particulate sources (refrigerator, fan, non-HEPA AC vents, cluttered hoods).
- **Environmental Monitoring:** No environmental monitoring procedures or documentation existed, and no EM was conducted during sterile processing.
- **Aseptic Process Validation:** Media fills were not conducted to simulate worst-case aseptic production.
- **Sterility Testing:** Finished sterile drug products, like Mertiadiate-Tc99m LEU, were not tested for sterility.
- **Production & Process Controls:** No written procedures for production and process controls to assure drug product identity, strength, quality, and purity. Specifically, the firm used unweighed, unverified (b)(4) from an unknown supplier

## Related Documents

- [483 - 2019-07-02](https://www.keypedia.com/records/483/shertech-pharmacy/21e9ef74-75ad-4abf-a1cf-d33e7a5c3281)

## Related Officers

- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.keypedia.com/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)

Company: https://www.keypedia.com/companies/shertech-pharmacy/0b691aa7-8df0-4573-8479-67b9dccaca5f

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9