| Compliance:
DSI is registered by the FDA, DEA
and the California Health and Human Services Department-Food
& Drug Branch. DSI maintains one of the most stringent
regulatory control programs in the industry. DSI holds
an excellent quality and compliance record with the regulatory
authorities. DSI's seven (7) employee and one hundred
and twenty (120) step documented production process assures
full compliance to all applicable cGMP's (current Good
Manufacturers Practices).
DSI maintains over 42 separate logs
that must be completed every day of operation. These records
document and monitor facility temperature, humidity, air
pressure differentials, facility and equipment maintenance,
equipment cleaning procedures, equipment process validation
systems, and many other critical production and drug storage
parameters to assure maximum product quality, purity,
safety and tractability.
DSI packages Penicillin and Cephlosporin
antibiotics in separate negative air flow packaging rooms.
This process is designed to prevent antibiotic contamination
of non-antibiotic products and cross contamination between
Penicillin and Cephlosporin products.
This process supports
and allows DSI:
- The authority to package Controlled Narcotics -Schedule
II-V, all legend drugs, OTC's and nutraceuticals
- Original manufacturer's expiration date
- Product to patient level tracking
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