FDA 483 - Synthetopes Inc - May 16, 2019

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