# FDA 483 - Synthetopes Inc - May 16, 2019

Source: https://www.keypedia.com/records/483/synthetopes-inc/04d626b2-4a5a-401f-b61a-f8ef285ad44f

> FDA 483 for Synthetopes Inc on May 16, 2019. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Synthetopes Inc
- Inspection Date: 2019-05-16
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: The FDA Form 483 details multiple significant violations at a facility producing radiological and nuclear injectable drug products.

**Key Violations:**

*   **Lack of Sterility Testing:** No sterility testing is conducted for sterile drug products like Dimercaptosuccinic Acid (DMSA) kits, Sodium Thiosulfate Anhydrous (Sulfur Colloid) Kits, Pentetate Indium Disodium (In-111 DTPA), and Indium Oxypquinoline (In-111 Oxine).
*   **Inadequate Aseptic Process Validation:**
    *   The firm's Pharmacist was unsure of specific allowable requirements for a (b) (4) used to sterilize nuclear drug products, including Pentetoreotide, Mertiatide, PYP, Exametazime, DTPA, DMSA, Sulfur Colloid, and Tetrofosmin Kits.
    *   During aseptic production, the Pharmacist exited the cleanroom to weigh bulk substances and re-entered without changing gloves.
    *   Media fills did not adequately simulate worst-case aseptic production, covering only a fraction of the routine batch size and not replicating the entire process.
*   **Deficient Environmental Monitoring:**
    *   Environmental monitoring (surface and non-viable air) is performed after cleaning, not after production, yielding unreliable results.
    *   Expired sampling materials were used for surface sampling.
    *   Sterility

## Related Documents

- [483 - 2019-05-16](https://www.keypedia.com/records/483/synthetopes-inc/90d41bdf-b76a-4990-9713-a22ebe38660d)

## 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/synthetopes-inc/be7d7bfa-a2b4-40cf-891c-161fb33d2984

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